Assay Development

Development of Known Biomarker(s) into a Targeted Assay

If a biomarker has already been identified it can become a shorter development path to a companion diagnostic (CDx). These biomarkers are typically used for patient stratification and to identify individuals likely to  respond to  particular therapeutics. 

Target Engagement

Exosomal biomarkers can serve as indicators of target engagement via gene expression analysis.  When a therapeutic ‘hits’ its biological target, specific genes may become activated and can be used as biomarkers to determine drug efficacy. 

Longitudinal Monitoring

Longitudinal monitoring allows physicians to observe how patients respond during therapy and assess if the treatment regimen needs to be modified or replaced with a secondary therapeutic. Often, the biomarker that identifies treatment ‘responders’ is the same biomarker that is utilized for longitudinal monitoring.  Additionally, biomarkers that demonstrate target engagement are also used for longitudinal monitoring.  

Liquid biopsy assessment of exosomal biomarkers avoids two common obstacles during post-treatment longitudinal monitoring: access to tissue and biomarker identification using small amounts of blood. Exosome Diagnostics’ technology platform provides the requisite sensitivity as low as 0.5 mL of plasma.

Characterization of Clinical Trial Patients (Retrospective Testing)

Restrospective testing of clinical trials or biobanked samples allows for further analysis. Properly stored samples have shown to be stable for greater than 20 years when using our exosome isolation methods.